DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 27 February 2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear what further structural limitation claim 21 provides to the claimed invention. The claim merely recites what naturally causes thalamocortical excitation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over O’Reilly et al. (Peak-to-peak amplitude in neonatal brain monitoring in premature infants – previously cited) in view of Inder et al. (Lowered Electroencephalographic Spectral Edge Frequency Predicts the Presence of Cerebral White Matter Injury in Premature Infants – previously cited) further in view of Bell’462 (US Pub No. 2009/0018462 – previously cited) further in view of Barlow et al.’814 (US Pub No. 2006/0079814 – previously cited).
Regarding claims 1 and 2, O’Reilly et al. discloses a neural analysis and treatment system for monitoring preterm (premature) infants, the system comprising: a computing device having at least one processor and at least one computer-readable medium, the at least one computer-readable medium including instructions executable by the at least one processor (the method described in the 2. Methods section on page 2141 inherently requires the use of a system comprising at least one processor and at least one computer-readable medium including instructions executable by the at least processor); and one or more electrodes configured to measure electroencephalography (EEG) data of a patient (page 2141, section 2.2. EEG and aEEG recording); wherein the instructions, when executed by the at least one processor, cause the at least one processor to: receive EEG data of the patient from the one or more electrodes, wherein the EEG data includes raw EEG data, amplitude-integrated EEG (aEEG) data, range EEG (r-EEG) data, or a combination thereof (ABSTRACT, 2. Methods section), and generate information from the received diagnostic EEG data, the diagnostic information being used to determine neonatal brain maturation (ABSTRACT, 2. Methods section, 3. Results section, and first four paragraphs of 4. Discussion section).
O’Reilly et al. discloses all of the elements of the current invention, as discussed above, except for the generated information being spectral feature information. Inder et al. teaches that spectral edge frequency (SEF)-based measurements derived from received EEG data are useful for defining the presence and severity of white matter injury in preterm infants (see Conclusions). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of O'Reilly et al. to include a processor configured to determine an SEF measurement from the received EEG data, as taught by Inder et al., since it would be useful for defining the presence and severity of white matter injury in the preterm infants.
It is noted that O’Reilly et al. discloses that its one or more electrodes receive EEG data continuously for 72 hours after the infant’s birth (page 2141, section 2.2. EEG and aEEG recording, second paragraph). When the infant is being fed, the spectral feature information relates to thalamocortical excitation. Furthermore, the term “relates to” is a broad term that does not specifically define how the spectral feature information “relates to” thalamocortical excitation. Spectral feature information generated from any type of EEG data of an infant experiencing any type of sensory experience would “relate to” thalamocortical excitation.
O’Reilly et al. in view of Inder et al. discloses all of the elements of the current invention, as discussed above, except for developing a treatment plan based on the spectral feature information. Bell’462 teaches developing one or more treatment plans based upon a neural characteristic of a patient in order to provide an appropriate therapeutic response to the patient (page 5, section [0052]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of O’Reilly et al. further in view of Inder et al. to include a processor configured to develop one or more treatment plans based upon the spectral feature information, since Bell’462 teaches that it would allow a proper therapy to be provided to the preterm infant based on the determined neural condition of the preterm infant.
O’Reilly et al. in view of Inder et al. further in view of Bell'462 discloses all of the elements of the current invention, as discussed above, except for the treatment plan entraining electrophysiological development in a brain of the patient. Barlow et al.’814 teaches that an appropriate treatment plan for premature infants includes the use of a closed-loop non-nutritive suck entrainment stimulus device, the stimulus device comprising a somatosensory stimulus device comprising a pneumatically-charged device (see TITLE, ABSTRACT, SUMMARY, and sections [0009-0010], [0012], [0026], [0031], [0042], and [0045]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed for the treatment plan of O’Reilly et al. in view of Inder et al. further in view of Bell'462 to include use of the closed-loop non-nutritive suck entrainment stimulus device and method taught by Barlow et al.’814, since Barlow et al.’814 teaches that its device and method are an appropriate treatment plan for preterm infants. The treatment plan disclosed by Barlow et al.’814 entrains electrophysiological development in the brain of the preterm infant (which means that it alters cortical activity and/or promotes cortical adaptation of the preterm infant). In combination with O’Reilly et al. in view of Inder et al. further in view of Bell’462, the treatment plan would be based on the generated spectral feature information obtained from the received EEG data that is received from the one or more electrodes.
The closed-loop non-nutritive suck entrainment stimulus device of O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 is a somatosensory stimulus device configured to provide additional somatosensory stimuli to the patient. In the combination of O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814, the at least one processor is configured to generate one or more control signals to the somatosensory stimulus device to provide somatosensory stimuli to the patient, wherein the one or more control signals are generated in response to the EEG data received from the one or more electrodes.
Regarding claim 3, changes in the SEF measurements of O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 are monitored in order to allow the system to monitor the effect of the treatment on the patient. Changes in the SEF measurements are an SEF modulation of the EEG spectra of the received EEG spectra.
Regarding claims 4 and 5, by virtue of entraining electrophysiological development in the brain of the patient with the same type of somatosensory stimulus device as that of the claimed invention, the system of O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 entrains neurostructural development in the patient’s brain, wherein the neurostructural development in the brain of the patient includes development of cortical connections in the brain of the patient.
Claims 7-11 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814, as applied to claims 1 and 6, further in view of Shahaf et al.’569 (US Pub No. 2012/0296569 – previously cited).
Regarding claim 7, O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the at least one processor being configured to receive EEG data from the patient prior to, during, and after generating the control signal. Shahaf et al.’569 teaches receiving diagnostic information from a patient before, during, and after providing treatment to the patient. Shahaf et al.’569 receives the diagnostic information before, during, and after providing treatment in order to assess the effect of the treatment on the patient (sections [0047] and [0259]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 to include configuring its at least one processor to receive the EEG data of the patient from the one or more electrodes prior to, during, and after generating the control signal since Shahaf et al.’569 teaches that this would allow the system to monitor the effect of the treatment on the patient.
In the combination of O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 further in view of Shahaf et al.’569, the at least one processor is configured to generate a control signal to the somatosensory stimulus device to perform the generated treatment plan (as taught by Barlow et al.’814), wherein EEG data is received before, during, and after the treatment is provided in order to determine the effectiveness of the treatment (as taught by Shahaf et al.’569). This would include receiving post-treatment EEG data of the patient from the one or more electrodes after the treatment plan has been performed, generating post-treatment spectral feature information from the received post-treatment EEG data (as taught by Inder et al.), and determining an electrophysiological development level of the brain of the patient using the spectral feature information and the post-treatment spectral feature information (O’Reilly et al. in view of Inder et al. already determines a brain development level (brain maturation) of the patient according to the original spectral feature information, and when modified by Shahaf et al.’569, the system would determine the brain development level according to all of the available spectral feature information).
Regarding claim 8, as noted above with respect to claim 1, the post-treatment EEG data would include raw EEG data, amplitude-integrated EEG (aEEG) data, range EEG (r-EEG) data, or a combination thereof.
Regarding claim 9, as noted above with respect to claim 3, the post-treatment spectral feature information would include SEF modulation information of the EEG spectra of the received EEG data.
Regarding claims 10 and 11, the electrophysiology development level of the brain comprises a quantified cortical activity and a quantified cortical adaptation of the patient (any of the quantified SEF, aEEG, rEEG measurements, and any of the quantified changes of the measurements after each treatment session).
Regarding claim 21, as EEG data is received during the applied somatosensory stimuli treatment, the thalamocortical excitation is a result of synchronous volleys of oral mechanoreceptive afferent activity in maxillary and mandibular divisions of a trigeminal nerve evoked by the somatosensory stimuli.
Claims 12-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 further in view of Shahaf et al.’569.
Regarding claims 12-18 and 20, the sections of O’Reilly et al. cited in paragraphs 6 and 7 above, as modified by Inder et al., Bell’462, Barlow et al.’814, and Shahaf et al.’569, disclose a method comprising the steps recited in the claims.
Response to Arguments
Applicant's arguments filed 27 February 2025 have been fully considered and are not entirely persuasive.
Regarding the rejection of the claims under 35 U.S.C. 112(b), the amendments to the claims have overcome the previous indefiniteness rejections. However, as discussed in paragraph 4 above, the amendments have warranted a new rejection under 35 U.S.C. 112(b).
Regarding the rejection of the claims under 35 U.S.C. 103, Applicant’s arguments are not persuasive. Applicant argues that the purpose of Inder et al.’s SEF-based measurements is not the same as Applicant’s. This argument is not persuasive as prior art need not disclose the same intended use of a claimed invention; cited prior art is required to teach each structural element and corresponding function for a device/system claim, and each method step for a method claim. The cited combination of O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 teaches each structural limitation in the system claims.
Applicant’s argument that Inder et al. is silent with regard to “the spectral feature information relates to thalamocortical excitations” is also not persuasive. As noted in paragraph 6 above, O’Reilly et al. discloses that its one or more electrodes receive EEG data continuously for 72 hours after the infant’s birth (page 2141, section 2.2. EEG and aEEG recording, second paragraph). When the infant is being fed, the spectral feature information relates to thalamocortical excitation. Furthermore, the term “relates to” is a broad term that does not specifically define how the spectral feature information “relates to” thalamocortical excitation. Spectral feature information generated from any type of EEG data of an infant experiencing any type of sensory experience would “relate to” thalamocortical excitation. With specific regard to claims 12 and 21, with the addition of Shahaf et al.’569, EEG data is received during somatosensory stimuli treatment provided by a non-nutritive suck entrainment system. The spectral feature information generated from the EEG data received during somatosensory stimuli treatment relates to thalamocortical excitation.
The remainder of Applicant’s arguments are directed to the references individually, and not to the combination of references used to reject the claims. In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Niemarkt et al. (Maturational Changes in Automated EEG Spectral Power Analysis in Preterm Infants – previously cited) teaches that analyzing changes (a modulation) in an SEF measurement is useful for brain monitoring in preterm infants and for indicating functional cerebral maturation (page 529, right column, last sentence beginning with “West et al. (17)…” – page 530, left column, line 7).
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791